I have had the pleasure of working with Andrew and the team at Insight Regulatory for many years. They have consistently supported us by conducting our internal and supplier audits, ensuring our processes and procedures remain up-to-date and compliant with the latest regulatory requirements. Additionally, we have relied on their expertise for consultation and support in developing our Process Validations and Software Validation procedures, as well as maintaining FDA compliance. Their on-call support during audits puts my mind at ease. The team at Insight Regulatory is knowledgeable, capable, and approachable, always demonstrating a positive, can-do attitude. Whenever we need assistance, they are readily available to provide support.
We've had the pleasure of working with Andrew and the Insight team for several years, and their knowledgeable and pragmatic consultancy has been invaluable in the areas of biological safety, cleaning and sterilisation and more broadly supporting the upgrade of technical documentation. Their expertise has been critical in assisting with FDA and Notified Body responses, as well as our transition to EU MDR. Time and again, they've supported us at short notice and consistently delivered high-quality work. We truly appreciate their expertise, dedication, and professionalism, which has been essential to our ongoing success in navigating complex regulatory requirements.
We have worked with Andrew and Insight for the last year. He has provided expert regulatory advice to build a realistic strategy and time-plan to launch a range of medical devices. He has then worked hard to deliver a number of key actions including literature reviews, claim substantiation and supplier qualification. We look forward to continuing our collaboration to deliver the completion of all technical files, a successful launch and post-launch support. Andrew has the great combination of expertise with the ability to communicate this in simple language without losing any of the key points that need to be considered. He is very approachable and pragmatic, but with the right attention to detail. We at VBM would not hesitate in recommending Insight Regulatory for similar projects and look forward to continuing our work together in the future.
I cannot overemphasise the importance and value Andrew and the Insight team have provided to our company. Ocupeye has collaborated with key persons covering diverse disciplines to bring our medical device to market. Regulatory as part of the business jigsaw is complex and requires a thoroughly professional/reliable approach. We additionally needed pro-active leadership and an understanding and commitment to deadlines. Insight have delivered on all fronts and it is with pleasure I recommend Andrew’s company.
